Comparison of the Efficacy of Carpal Tunnel Release vs. Local Steroid Injection in the Management of Mild to Moderate Carpal Tunnel Syndrome: A Clinical Trial

Jafari, Davood; Shariatzadeh, Hooman; Najd Mazhar, Farid; Babaei, Reza; Mirkazemi, Masoud; Ayazi, Nazanin

doi:10.5812/soj.58159

Davood Jafari

¹, Hooman Shariatzadeh¹

, Farid Najd Mazhar¹

, Reza Babaei¹

, Masoud Mirkazemi¹

, Nazanin Ayazi²

1- Bone and Joint Reconstruction Reserch Center, Shafa Orthopedic Hospital, Iran University of Medical Sciences, Tehran, Iran
2- Department of Orthopedics, Rasoul - e - Akram Hospital, Iran University of Medical Sciences, Tehran, Iran

Keywords: Carpal Tunnel Syndrome, Carpal Tunnel Release, Local Steroid Injection

Full-Text [PDF 116 kb] (732 Downloads) | Abstract (HTML) (1756 Views)

Full-Text: (1318 Views)

Abstract

Results: In total, 68 patients (33 in the LSI and 35 in the CTR group), with the mean age of 45.8 ± 8.1 years and mean BMI of 30.5 ± 6.1 kg/m² were included. The baseline clinic - demographic characteristics of the patients were not significantly different between the 2 study groups. Both treatments significantly improved the FSS (p = 0.002 for LSI and p = 0.001 for CTR) and SSS (p = 0.001 for both groups). However, no significant difference was observed between FSS (p = 0.36) and SSS (p = 0.29) of the 2 groups. Although the patients’ satisfaction was also not significantly different between the 2 groups, the number of completely satisfied patients was more in the LSI group.

Copyright © 2018, Shafa Orthopedic Journal. This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/) which permits copy and redistribute the material just in noncommercial usages, provided the original work is properly cited

1. Background

Carpal tunnel syndrome (CTS) is the most common compressive neuropathy of upper extremity. Symptoms include paresthesia, numbness (hypoesthesia), tingling of thumb, index, middle and radial half of ring fingers, and deep pain at the thenar region. In severe cases weakness and atrophy of abductor pollicis muscle and opponens pollicis muscle are evident (1). Several risk factors such as female gender, age of 30 - 60 years, obesity, and others have been reported for CTS (2-5). Although underlying medical condition is not detectable in many patients, conditions such as tumor, infection, and distal radius fracture can cause CTS through putting an excess pressure on the wrist and on the median nerve (6). Sleep disturbance due to paresthesia is the main diagnostic clue for CTS (7).

Both conservative and surgical treatments are currently used for the management of CTS. Conservative options for CTS treatment include splinting, nonsteroidal anti-inflammatory drugs (NSAIDs), local steroid injection (LSI), and systemic steroids. Surgical treatment of CTS includes surgical decompression through carpal tunnel release (CTR), which is usually applied for patients with progressive and persistent signs and symptoms, especially the thenar atrophy (8).

Although CTR and LSI have been widely used in the treatment for CTS, there is no clear consensus regarding their effectiveness in the treatment of mild to moderate CTS as well as if one of these methods overweighs the other one in terms of patients’ outcome and satisfaction.

2. Objectives

3. Methods

All patients with the diagnosis of mild to moderate CTS, admitted at the Shafa orthopedic hospital (Tehran, Iran), from February 2005 to April 2008, were randomly assigned into the study groups. A CTS diagnosis was made through the evaluation of patients’ history of the symptoms, confirmed by its signs such as Tinel, Phalen, and Durkan compression (9). CTS severity was determined by the electrophysiological study all performed at 1 center (Shafa hospital electrophysiological study center). In this respect, nerve conduction velocity (NCV) were graded according to the previously introduced neurophysiological grading with a spectrum of grades from 0 to 6, showing normal, very mild, mild, moderate, severe, very severe, and extremely severe, respectively (10).

Those patients in whom electrophysiological findings were not in accordance with clinical findings were excluded from our study. All patients with severe CTS were excluded from the study as well. Moreover, patients with underlying diseases such as double crush syndrome, rheumatoid arthritis, diabetes mellitus, and thyroid disorders were excluded from the study.

At admission and 6 months after the treatment, the outcome was assessed by the Boston Carpal Tunnel Questionnaire (BCTQ), which consistied of the symptoms severity scale (SSS) with 11 questions and functional status scale (FSS) with 8 questions. Each question contained a scale of 1 - 5 points, in which 1 indicates no symptoms and 5 indicates severe symptoms (11). Patients’ satisfaction was evaluated with a five - point scale (from 0 to 5) indicating completely satisfied, almost satisfied, moderately satisfied, somewhat satisfied, and dissatisfied, respectively.

In total, 128 CTS patients were referred to our center during the study period. In 24 patients, severe CTS was noticed. These patients were excluded from the study. In 10 patients electrophysiological findings were not in accordance with the clinical findings. These patients were removed from the study as well. Underlying disorders led to the exclusion of 12 patients. The remaining 82 patients were randomly assigned into 2 study groups, 41 patients each (Figure 1). Predesigned blocks were used for randomization purposes. A computer-generated random number list was used for random allocation of the patients. Group assignment remained concealed from investigators during the course of data gathering. In total, 14 patients missed the final evaluation session (8 in steroid injection and 6 in CTR group). The final evaluation was performed for the remaining 68 patients (33 in steroid injection and 35 in CTR group).

Figure 1. The flow diagram of the inclusion and exclusion of carpal tunnel syndrome (CTS) patients.

This RCT has been recorded in the Iranian clinical registry center under the code number of IRCT 20170.183246 N1. Moreover, it was approved by the ethical committee of Iran University of Medical Sciences, and written consent was obtained from each patient before inclusion in the study.

3.1. Technique

Steroid injection and CTR were done by a fellowship trained hand surgeon. For LSI group, a dose of 40 mg/mL of Triamcinolone Acetonide was injected into the carpal tunnel at the volar aspect of the wrist, just ulnar to the palmaris longus tendon, with a syringe making an angle of 60° to the horizon, and entering 10 mm into the transverse carpal ligament depth. If the patient felt paresthesia in the hand during the procedure, the process was halted and repeated again from the first step.

Carpal tunnel releases were done according to Green’s classic approach (1). Accordingly, a curvilinear incision of about 3 cm was made 6 mm ulnar to thenar crease in line with 4^th finger longitudinal axis. Then, 2 cm of antebrachial fascia, transverse carpal ligament, and palmar fascia between the thenar and hypothenar muscles were incised. Carpal tunnel was examined for possible abnormalities like ganglion cyst. Median nerve external neurolysis only performed when median nerve was adherent to radial leaf of the transverse carpal ligament. Short arm splints were applied for 2 weeks after the operation.

3.2. Statistical Analysis

Data were analyzed using IBM SPSS for Windows version 16. Descriptive statistics were presented as frequencies (%), means ± standard deviation (SD), or medians with ranges as appropriate. Comparison of pre - and post - operative scores within each group were performed using paired t - test for parametric variables or Wilcoxon signed ranks test for nonparametric variables. Change of the scores across the 2 treatment groups were investigated with independent samples t - test for parametric variables or Mann - Whitney U test for nonparametric variables. Chi - square test was used for the comparison of categorical variables. A P-value of less than 0.05 was considered significant.

4. Results

The outcome of 68 patients with mild to moderate CTS, from those, 33 underwent steroid injection and 35 were treated surgically, were evaluated in this study. The study population consisted of 12 males and 56 females with the mean age of 45.8 ± 8.1 years. The mean body mass index (BMI) of the patients was 30.5 ± 6.1 kg/m². The clinical and demographic characteristics of the 2 study groups have been demonstrated and compared in Table 1.

Table 1. Comparison of Clinical and Demographic Characteristics of the Patients^a,b

Variable	Steroid Injection Group (N = 33)	CTR Surgery Group (N = 35)	P Value
Age (years)	45.4 ± 8.4	46.2 ± 7.8	0.63
Gender			0.51
Male	6 (18)	6 (17)
Female	27 (82)	29 (83)
BMI (kg/m²)	30.2 ± 6.2	30.7 ± 5.8	0.47
Preoperative Signs			0.11
Tingling	33 (100%)	33 (94%)
Finger numbness	31 (94%)	32 (91%)
Tinnel	23 (70%)	25 (71%)
Phallen	28 (85%)	32 (91%)
Compression Test	33 (100%)	32 (91%)
Pain	18 (55%)	25 (71%)
Weakness	9 (27%)	21 (60%)
Mean SSS change	0.69	0.72	0.29
Mean FSS change	0.21	0.23	0.36
Median patient satisfaction score	5	5	0.3

Abbreviations: CTR, Carpal Tunnel Release; FSS: Functional Status Scale; SSS, Symptom Severity Scale.

^aData are shown as mean ± SD or number (%).

^bA P - value of <; 0.05 is considered significant.

In the LSI group, mean SSS changed from 2.27 ± 0.6 at baseline to 1.58 ± 0.4 at final evaluation (6 weeks after the treatment) (p = 0.001). Mean FSS changed from 1.5 ± 0.47 at baseline to 1.29 ± 0.31 at final evaluation (p = 0.002). Median patient satisfaction score was 5 (ranged 2 - 5).

In the CTR group, mean SSS changed from 2.32 ± 0.8 at baseline to 1.6 ± 0.5 at final evaluation (6 weeks after the treatment) (p = 0.001). Mean FSS changed from 1.62 ± 0.55 at baseline to 1.39 ± 0.48 at final evaluation (p = 0.001). Median patient satisfaction score was 5 (ranged 2 - 5).

SSS and FSS change was not significantly different between the 2 study groups (p = 0.29 and p = 0.36, respectively). A number of 24 patients in the LSI group and 21 patients in the CTS group were completely satisfied with the results of therapy. However, this difference of patient satisfaction between the 2 study groups was not statistically significant (p = 0.3).

5. Discussion

In spite of the high incidence of CTS, there is no universally accepted procedure for its treatment. Although surgical treatment is generally accepted in severe cases, it is not clear if surgical treatment overweighs the non - surgical approaches such as steroid injection in the treatment of CTS patients with mild to moderate symptoms (12).

Here we designed an RCT to compare the outcome of CTR vs. LSI in CTS patients with mild to moderate symptoms. According to our results, both treatments significantly improved the symptoms at a follow-up period of 6 months. No significant difference was observed between the 2 groups in terms of functional status, symptom severity, and the patients’ satisfaction. Even so, the number of patients with complete satisfaction was more in the LSI group.

Hui et al. assessed the efficacy of surgery vs. steroid injection in relieving CTS symptoms in a clinical trial study composed of 50 patients, 25 patients for each group. Over a follow - up period of 20 weeks, their results showed a better symptomatic and neurophysiologic outcome in patients of the CTR group (13).

Ly - Pen et al., in a randomized clinical trial, compared the efficacy of surgical decompression vs. LSI in 163 patients with clinical diagnosis and neurophysiological confirmation of CTS, over a follow - up period of 2 years. Based on their results, both LSI and CTR were effective in alleviating symptoms of CTS. However, surgery had an additional benefit (14).

While we observed no significant difference between the outcome of LSI and CTR in the management of CTS, other investigations showed the priority of surgical decompression. The present inconsistency could be associated with the difference in the follow - up period of the studies, which has also been pointed out in earlier investigations.

Demirci et al. compared the efficacy of LSI and open CTR in 90 CTS patients. Although both groups showed significant improvement at 3 and 6 months follow - ups, by the end of follow - up, 5% of the hands in CTR group and 13% of the hands in the LSI group showed electrophysiological worsening. Moreover, 5% of the hands in the CTR group and 22% of the hands in the LSI group showed symptomatic worsening. They concluded that although steroid injection provides an improvement comparable with surgical decompression, this improvement is not long-lasting (15).

The study of Ismatullah, in a short series of 40 patients, also showed that steroid injection only provides transient relief in CTS, whereas CTR operation results in long-lasting alleviation (16).

Shi et al., compared the efficacy of surgical treatment of CTS with conservative treatment in a systematic review. They found that while the positive impact of conservative management plateaus within 3 months, surgical intervention has a superior benefit in both symptoms and function at 6 and 12 months after the treatment. They also found that the patients who underwent CTR surgery were 2 times more likely to have normal nerve conduction studies. Even so, the complication and side effects of CTR were more considerable as well. Altogether, they concluded that since conservative management is effective in relieving symptoms in a certain proportion of cases and can avoid the complications of the surgery, it remains a justified first line treatment (8).

Based on the results of earlier investigations, it seems that longer follow-up of the patients or multi - steps evaluation of outcome would further clarify the potential of each treatment in the management of CTS. Consequently, short - term and single - step follow-up of the patients could be considered as the biggest limitations of our study.

Our study showed no significant difference was observed between the outcome of CTS patients following the LSI or CTR. However, at a mean follow - up period of 6 months, the number of patients with complete satisfaction was more in the LSI group. Despite this privilege, longer follow - up period of patients is needed to determine the durability of each treatment.

References

1. Cohen MS, Hotchkiss RN, Kozin SH, Pederson WC, Wolfe SW. Green's Operative Hand Surgery. Elsevier; 2017.
2. Mansfield M, Thacker M, Sandford F. Psychosocial Risk Factors and the Association With Carpal Tunnel Syndrome: A Systematic Review. Hand (N Y). 2017:1.5589447177364E+15. doi: 10.1177/1558944717736398. [PubMed: 29078710].
3. Shakir EA, Nazar Z. Obesity increase the risk of carpal tunnel syndrome. International Journal Of Scientific Research And Education. 2017;5(4).
4. Shariatzadeh H, Mohseni MM. Incidence of Complex Regional Pain Syndrome Following the Carpal Tunnel Release Surgery. Shafa Orthopedic Journal. 2017;4(4).
5. Jafari D, Najd Mazhar F, Joudi S, Keyhan Shokooh H, Shariatzadeh H, Hassani Shariat Panahy P. Trapeziohamate Distance in Carpal Tunnel View as a Risk Factor for Carpal Tunnel Syndrome. Shafa Orthopedic Journal. 2015;2(4).
6. Duncan SFM, Kakinoki R. Carpal Tunnel Syndrome and Related Median Neuropathies: Challenges and Complications. Springer; 2017.
7. Patel A, Culbertson MD, Patel A, Hashem J, Jacob J, Edelstein D, et al. The negative effect of carpal tunnel syndrome on sleep quality. Sleep Disord. 2014;2014:962746. doi: 10.1155/2014/962746. [PubMed: 24693441].
8. Shi Q, MacDermid JC. Is surgical intervention more effective than non-surgical treatment for carpal tunnel syndrome? A systematic review. J Orthop Surg Res. 2011;6:17. doi: 10.1186/1749-799X-6-17. [PubMed: 21477381].
9. De Smet L, Steenwerckx A, Van den Bogaert G, Cnudde P, Fabry G. Value of clinical provocative tests in carpal tunnel syndrome. Acta Orthop Belg. 1995;61(3):177-82. [PubMed: 8525813].
10. Bland JD. A neurophysiological grading scale for carpal tunnel syndrome. Muscle Nerve. 2000;23(8):1280-3. [PubMed: 10918269].
11. Padua L, Padua R, Aprile I, Caliandro P, Tonali P. Boston Carpal Tunnel Questionnaire: the influence of diagnosis on patient-oriented results. Neurol Res. 2005;27(5):522-4. doi: 10.1179/016164105X17260. [PubMed: 15978179].
12. Verdugo RJ, Salinas RA, Castillo JL, Cea JG. Surgical versus non-surgical treatment for carpal tunnel syndrome. Cochrane Database Syst Rev. 2008;(4). CD001552. doi: 10.1002/14651858.CD001552.pub2. [PubMed: 18843618].
13. Hui AC, Wong S, Leung CH, Tong P, Mok V, Poon D, et al. A randomized controlled trial of surgery vs steroid injection for carpal tunnel syndrome. Neurology. 2005;64(12):2074-8. doi: 10.1212/01.WNL.0000169017.79374.93. [PubMed: 15985575].
14. Ly-Pen D, Andreu JL, Millan I, de Blas G, Sanchez-Olaso A. Comparison of surgical decompression and local steroid injection in the treatment of carpal tunnel syndrome: 2-year clinical results from a randomized trial. Rheumatology (Oxford). 2012;51(8):1447-54. doi: 10.1093/rheumatology/kes053. [PubMed: 22467087].
15. Demirci S, Kutluhan S, Koyuncuoglu HR, Kerman M, Heybeli N, Akkus S, et al. Comparison of open carpal tunnel release and local steroid treatment outcomes in idiopathic carpal tunnel syndrome. Rheumatol Int. 2002;22(1):33-7. [PubMed: 12120909].
16. Ullah I. Local steroid injection or carpal tunnel release for carpal tunnel syndrome-Which is more effective?. J Postgrad Med Inst (Peshawar-Pakistan). 2013;27(2).

Subject: Knee surgery
Received: 2019/09/9 | Accepted: 2018/02/15 | Published: 2018/02/15

Rights and permissions
	This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.